BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3952121 · Received May 12, 2014

    Report

    Report Number
    1218950-2014-02681
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Report Date
    April 17, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART MRX DEFIBRILLATOR DISPLAYED A, "SHOCK EQUIP MALFUNCTION INOP" MESSAGE AND FAILED OPERATIONAL CHECK FOR THE DEFIB TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284252 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1